Purpose

The goal of this single-arm, observational pilot study is to learn about the safety, feasibility, preliminary efficacy of TMS for the treatment of depression in people with MS. Participants will receive outpatient TMS treatment over the course of 5-6 weeks. Participants will complete validated questionnaires and exams before, during, and after treatment.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Established diagnosis of multiple sclerosis (any subtype) by 2017 McDonald criteria - Established diagnosis of major depressive disorder (MDD) by DSM-5 criteria - Eligible for transcranial magnetic stimulation (rTMS) for depression

Exclusion Criteria

  • MS relapse and/or steroid use within 3 months - Active suicidal ideation - History of seizure/epilepsy, brain tumor, or stroke - History of bipolar disorder or psychosis - Currently or planning to become pregnant

Study Design

Phase
Study Type
Observational
Observational Model
Case-Only
Time Perspective
Prospective

Recruiting Locations

More Details

Status
Recruiting
Sponsor
University of Utah

Study Contact

Kathleen Shangraw, MD
8015832500
kathleen.shangraw@hsc.utah.edu

Detailed Description

Multiple sclerosis (MS) is a chronic, immune-mediated disease of the central nervous system. Depression, or major depressive disorder, is highly prevalent in people with MS and often has a serious impact on quality of life. MDD can be difficult to treat with medications in MS. Transcranial magnetic stimulation (TMS) is a safe and approved treatment for treatment-resistant depression in the general population. However, little is known about the use of TMS for MDD in people with MS. This pilot study will evaluate the safety, feasibility, and preliminary efficacy of TMS for MDD in MS. Participants will receive outpatient neuronavigated-TMS for MDD. Various measures of MS and MDD symptoms will be monitored over the course of treatment. Clinical brain imaging will also be compared before and after TMS.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.